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OpenTrials
Completed

NCT Number: NCT02241252

Using an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients

This study will validate the recording accuracy of a specific electrical interval of the heart, the QT interval, between an iPhone rhythm strip recording and a traditional 12-lead electrocardiogram (ECG). These measurements will occur in hospitalized patients that are starting either sotalol or dofetilide, since both of these medications can prolong the QT interval.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

Patients that were already selected to begin either dofetilide or sotalol in the hospital, will be included in the study. Patients will receive an ECG before and 2 hours after each dose of the medication, which is done to monitor the QT interval. In addition, patients that consent to participate in the study will have an iPhone ECG recording taken in lead positions that correspond to leads I,II, and III.

These recordings will be compared and analyzed to assess the accuracy of the QT interval recordings between the two methods.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • initiation of sotalol or dofetilide
  • inpatient at University hospital

Exclusion criteria

  • none

Treatment and study plan

iPhone ECG

Device

Please see detailed description for additional information.

Other names: AliveCor iPhone ECG

Primary outcomes

  1. QT interval measurement (in milliseconds)

    Time frame: Participants will be followed for duration of hospital stay during which dofetilide or sotalol are being started, an expected average of 3 days

    The QT interval (measured from the start of the QRS to the end of the T wave) will be measured on the 12-lead ECG and on the iPhone rhythm strip recording. Both measurements will be recorded in milliseconds and will be statistically analyzed for bias and agreement.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Clinical Validation of an iPhone ECG System, QT Substudy

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 16, 2014
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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